Licensure

Please take a minute to learn the facts about licensure and discover why this is so important for our healthcare community and you.

State licensure for laboratory personnel is discussed and believed to be one way to ensure the quality of laboratory testing and patient safety. There have been mixed results around the United States about which States require licensure or not. We have observed that some legislators believe that Federal CLIA regulations are sufficient to protect the public and that there are generally not enough laboratory problems to warrant further regulation.

The National ASCLS and the State of Missouri ASCLS Chapter (ASCLS-MO) have long been supporters of the need for licensure. Significant effort has been taken to draft model licensure bill(s), collect supporting documentation for licensure, and support State efforts about licensure when they have come up.

Timely and accurate laboratory testing results are a critical factor in the diagnosis and treatment of patient illness and disease. A combination of three (3) mutually dependent factors must be in place in order to have laboratory testing be timely, accurate, and performed correctly. These three (3) factors make up the proverbial stool, with the factors being (1) personnel standards, (2) quality assurance, which includes quality control, and (3) proficiency testing. If any one (1) of these factors is deficient, like a broken leg on a stool, it results in substandard quality and jeopardizes patient care. State licensure ensures that there is adequate education, training, and experience for all personnel performing laboratory testing. It further ensures that these personnel remain current with annual continuing education requirements. State licensure can play a significant role in preventing some of the following problems related to inaccuracies in laboratory testing: misdiagnosis, incorrect or inappropriate treatment, added or unnecessary testing, unneeded hospital admissions, progression of severe illness, and even death.

Where Is Licensure Required At Today

There are currently ten (10) states with laboratory personnel licensure (California, Hawaii, Florida, New York, North Dakota, Tennessee, Louisiana, Nevada, West Virginia, and Montana). Puerto Rico also has licensure. The components of the law vary state-to-state but usually include an annual licensing fee (some are bi-annual), a provision for continuing education, a minimum education, and professional competency requirements.

If a Medical Laboratory Scientist (MLS) or Medical Laboratory Technician (MLT) plans to locate in a state with licensure, that state should be contacted for specific information relative to that state’s laboratory practice act. This contact should be made as early as possible after the location decision has been made. Most states (except California) require documentation of certification from an acceptable certification agency. Other things to expect are fingerprinting (Louisiana, possibly other states), documentation of certification, and documentation of education, training, and competency. Some states require documentation of a defined number of contact hours prior to issuing a license. California does not recognize any certification or any other state license. Check with other states about reciprocity; most give reciprocity for another state license as stringent or more stringent than that state.

Definition Disambiguation

By definition, to license is to authorize by a legal permit or to give formal permission from a constituted authority. Licensure is a governmental activity taken on behalf of the public to protect that public from potential harm. Licensure of personnel is often contrasted with certification, which is a private-sector activity. A significant difference involves the consequences of engaging in practice without each credential. If a license is required to practice a profession in a state, it is unlawful to work without one, and the consequences of doing so are very serious. Not being certified may make it more challenging to get a job, but it is not unlawful to work without it.

Advantages and Disadvantages of Licensure

Pros

  • Improved patient safety
  • Creates a level playing field for all laboratories
  • Strengthens the recognition of our profession

Cons

  • Additional costs and paperwork to obtain a license
  • Additional regulatory overhead
  • Adjustments or shifts in certain aspects of control within the laboratory
Frequently Asked Questions (FAQs) About Licensure

Why is licensure for laboratory personnel important?
Licensure helps to ensure that universal quality standards can be set for laboratory testing. This is something that medical laboratory professionals desire. Licensure further helps patients ensure that they can rely upon their test results to be accurate regardless of where the tests are performed or who performs them. An added benefit of licensure is reduced healthcare costs through the net reduction of repeated laboratory tests to verify results. The well-trained and highly competent medical laboratory professionals also assist the providers in selecting the correct tests at the right time, and in interpreting the test results to ensure optimal patient care.

I took the national certification exam, now I’m licensed, right?
Short answer: no. National certification exams are distinct from licensure. Certification exams are operated within the private sector and are a voluntary action that you take to confirm that you, the certificant, have the required education, training, and experience to perform expected laboratory work. Licensure, on the other hand, is a requirement that is operated by a State government that grants the licensee the right to perform activities for which you are licensed. For States that require licensure, individuals that are not licensed are not allowed to perform the requisite activities.

Aren’t hospitals required to hire certified personnel to work in the laboratory?
Short answer: no. This is a common misunderstanding. Many hospitals are free to hire laboratory personnel that only have a high school diploma, while still meeting CLIA requirements. These non-certified staff are not required to have any formal education or training beyond high school. Additionally, countless laboratory tests are performed every day in settings other than hospitals.

Will this create, contribute to, or make staffing shortages worse?
Short answer: no. Research on this topic has resulted in studies that have shown that States with licensure do not have any worse staffing shortages or increased shortages vs. States that do not have licensure.

Will there be an increase in wages for licensed personnel?
This can be highly dependent on the facility and other factors. However, research studies on this topic have shown that wages were not significantly different in States with licensure vs. the States that did not have it.

Will I have to take another test?
This can vary depending on the State that we are talking about. Generally speaking, the answer is no. Many States with licensure have not developed their own test. In lieu of creating their own test, these States recognize specific national certification exams as part of the licensure requirements. These States also often require that licensed laboratory personnel have a bachelor’s degree. Generally, no additional exam is required.

Who will have to be licensed to perform laboratory tests?
This can vary depending on the State that we are talking about. Generally speaking, anyone that performs moderately complex or highly complex laboratory tests will have to be licensed to perform those tests. This would include all settings or environments where these laboratory tests would be performed (i.e., clinics, physician offices, hospitals, reference labs, etc.). There would be a few exceptions to this, with Federal laboratories being the big one since States have no authority to regulate those. Facilities that only perform waived tests will not likely have to employ licensed personnel.

Will I lose my job if I am currently working in a laboratory but don’t meet the requirements for a license?
Generally, the answer would be no. There is always a time period for which new legislation becomes active. Further, most States that have adopted licensure add “grandfather” language to the bill that accounts for this scenario. Often, this language states something to the effect that staff employed in a laboratory that don’t meet the licensure requirements will be allowed up to one (1) year to apply for and receive a license. After the first year of licensure implementation, all applicants would be required to meet all of the requirements for licensure.

How much will a license cost me?
This can vary depending on the State that we are talking about. Generally speaking, the fee(s) for the license will be determined by the State licensure board. This is outlined in the licensure legislation that is enacted by the State. The fee(s) associated with licensure are generally calculated in a manner that would be enough to cover the expenses of reviewing, granting, operating, and enforcing the licenses. Generally, there is no additional cost to the taxpayer for laboratory licensure.

What if I’m already licensed in another state and want to move to Missouri? Will my out-of-state license be recognized?
Most of the legislation related to laboratory licensure allows for the recognition of other State licenses. This recognition usually requires that the foreign State’s licensure requirements be as stringent as the home State and that they usually require a bachelor’s degree and a specific national certification to be held by the licensee.

What Can I Do To Help With Licensure

We need your help in spreading the good word about licensure. Tell your friends, your family, your social media contacts, and anyone that you encounter. More importantly, please reach out to your legislators to let them know about the need for licensure and all of the benefits that it brings. You can also work with your facility to invite legislators to come out to your laboratory and see what it is that we do, the need for highly trained and skilled personnel, and how important we are to the overall patient care process.